The National Institute for Health and Care Excellence issued draft guidance Thursday recommending against routine NHS use of Novartis' Aimovig (erenumab) for preventing migraine. The agency determined that the injectable CGRP receptor antagonist, which costs around 5000 pounds ($6385) per year, is not cost effective.
The European Commission approved Aimovig in July last year for the prevention of migraine in adults experiencing four or more migraine days per month. The product had earlier gained clearance in the US, where it is co-marketed with Amgen, marking the first regulatory authorisation of an anti-CGRP drug.
NICE assessed the use of Aimovig for preventing chronic and episodic migraine in adults who have four episodes or more of migraine every month and where at least three other preventive treatments have failed. Meindert Boysen, director of the agency's Centre for Health Technology Evaluation, noted that while the drug has "been shown to be clinically effective compared with best supportive care…there was not enough evidence to suggest that it is more effective than botulinum toxin type A for people with chronic migraine, which NICE already recommends."
Boysen added that "for both the chronic and episodic migraine populations there was no evidence to show that [Aimovig] is effective in the long-term in people for whom three previous preventive treatments had failed." Despite Novartis offering a confidential price discount on the product, NICE noted that the clinical trial evidence provided by the company does not fully reflect patients seen in the NHS and does not include all the relevant comparisons with other drugs and outcomes.
Boysen remarked "we will work with the company to ensure that they are given every opportunity to address the issues highlighted in these provisional recommendations." NICE added that comments on the draft recommendations are open to January 31.
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